FDA’s New RWE Guidance Provides Recommendations for Sponsors Conducting Non-Interventional Real-World Studies and Describes the Potential to Use RWE for Initial Approvals in One Limited Circumstance
FDA Law Blog
SEPTEMBER 10, 2023
The guidance also discusses ensuring that FDA has necessary access to the RWD, which requires sponsors ensuring that they are able to submit patient-level data for any clinical study included in a marketing application. The COVID-19 vaccines were initially authorized under EUAs, but their approvals do not appear to have been based on RWE.
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